Multiomic Diagnostics in Youth With Psychosis

NCT05457140 | Recruiting FDA Device

• 1 other identifier: 801937
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Rady Children's Institute for Genomic Medicine seeks to understand the genomes and immune systems in 15 children and adolescents who are admitted to Rady Children's Hospital Child and Adolescent Psychiatry Service with psychotic symptoms or schizophrenia. Cutting-edge genome and protein sequencing technology will be used to better understand how immunological and genetic assessments may improve our ability to identify the cause of psychosis and impact care. The investigator also hopes to identify new genetic and/or autoimmune causes of psychosis that may inform new treatment for future patients.

Conditions

Psychosis

Keywords

Genomic; Pediatric; Rady Children's Hospital

Outcome Measures

Primary Outcomes (1)

• Diagnostic rate of brain reactive autoantibodies

  Diagnostic rate of brain reactive autoantibodies via genomic and whole human proteome programmable phage display immunoprecipitation sequencing (PhIP-Seq)

  2 years

Study Arms (1)

Enrollees - WGS

EXPERIMENTAL

These participants will be subject to whole genome sequencing and Phage ImmunoPrecipiation sequencing (PhIP-Seq) to identify genetic changes and novel antibodies associated with psychosis.

Genetic: Genetic: Genomic sequencing and molecular diagnostic results, if any.; Diagnostic Test: Phage display ImmunoPrecipiation Sequencing (PhIP-Seq)

Interventions

Genetic: Genomic sequencing and molecular diagnostic results, if any. GENETIC

Genomic sequencing results may be used for diagnosis and treatment of participants.

Enrollees - WGS

Phage display ImmunoPrecipiation Sequencing (PhIP-Seq) DIAGNOSTIC_TEST

Whole Proteome programmable phage display immunoprecipitation sequencing will be used to diagnose known and novel autoantibodies.

Enrollees - WGS

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Individual in whom one of the following criteria is met:
• Child/adolescent admitted to the Rady Children's CAPS with symptoms of first break psychosis
• Biological parents of child/adolescent enrolled in this study for the purposes of reflex testing. Family members are eligible for participation in this study if they are presumed genetically related to a patient participant.

You may not qualify if:

• Already received any prior whole genome sequencing or exome sequencing.
• Unable to approach the family or patient for enrollment.
• Unable to obtain informed consent.
• Family members are ineligible for participation in this study if:
• They are known to not be genetically related to the child/adolescent patient participant
• They are a member of a protected research population

Sponsors & Collaborators

• Rady Pediatric Genomics & Systems Medicine Institute: lead

Study Sites (1)

Rady Children's Hospital San Diego

San Diego, California, 92123, United States

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Aaron Besterman, MD

  Rady Pediatric Genomics & Systems Medicine Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aaron Besterman, MD

CONTACT

858-576-1700; abesterman@health.ucsd.edu

Corrine Blucher, BS

CONTACT

858-576-1700; cblucher@rchsd.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist, Clinical Investigator

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 13, 2022
• Study Start: October 10, 2022
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

US (1)